Actalent
Sr. Principal Software Quality Engineer
– Pay Rate: $85/hour
Job Summary Actalent is hiring a Sr. Principal Software Quality Engineer to lead quality engineering activities for both software and hardware product development in the medical device industry.
Work Environment
Hybrid – local candidate preferred, onsite 3 days per week with remote flexibility and travel to site as needed.
Office hours 8am-5pm Pacific Time.
Responsibilities
Provide Quality Engineering leadership for software and hardware product development teams.
Lead design control risk management and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross‑functional product development team members.
Lead the development and maintenance of the Risk Management File (RMF), including risk management plans, hazard analysis, dFMEAs, pFMEAs and the risk management report.
Provide Quality Engineering input for review and approval of the Design History File (DHF) and associated documentation; oversee quality oversight and approval of product development plans, design inputs/outputs, verification and validation, and review of test plans, protocols and reports.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the subject matter expert for software quality; collaborate with teams on code reviews, software security analysis, and the software BOM lead implementation of best practices for software quality processes.
Participate in design reviews to ensure effective development, transfer and maintenance of the product hardware and software throughout the product lifecycle.
Support the successful transfer and hyper‑care phase of design and design modifications into production/field deployment.
Provide Quality Engineering support for anomalies (software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects; guide triage and remediation efforts.
Secondary / Backup Responsibilities
Lead changes to the Quality System based on new regulations, guidance documents, industry standards and observations.
Own the resolution and timely closure of CAPAs as they relate to the design control process.
Provide Quality Engineering support for released products interfacing with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management.
Qualifications
8 years of progressive Quality Engineering experience in the medical device industry with hands‑on support for hardware and software development.
Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304 and IEC 62366.
Experience in the design, development, verification, validation and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non‑embedded software.
Experience in the deployment of quality engineering tools for design and process improvement and extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with the ability to manage multiple projects independently while prioritizing work and advocating for quality and regulatory compliance.
Comfortable working in a high‑growth company with rapidly evolving needs, responsibilities and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis software (e.g., Minitab) and other business software.
Additional Qualifications
Certified ASQ CQE and/or Six Sigma Black Belt/Green Belt preferred.
Experience with artificial intelligence working within an AAMI TIR45 framework and SaMD is preferred.
Experience supporting development of classic and artificial intelligence AI software algorithms and deep understanding of cloud infrastructure is preferred.
Education and Experience
B.S./M.S. in a relevant engineering field (e.g., biomedical software, electrical engineering, etc.) or equivalent scientific degree.
Physical Demands and Work Environment
Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
Experience Level Intermediate Level
Pay and Benefits
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan (Pre‑tax and Roth post‑tax contributions available)
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Application Deadline This position is anticipated to close on Oct 28, 2025.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, please email actalentaccommodation@actalentservices.com for additional accommodation options.
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– Pay Rate: $85/hour
Job Summary Actalent is hiring a Sr. Principal Software Quality Engineer to lead quality engineering activities for both software and hardware product development in the medical device industry.
Work Environment
Hybrid – local candidate preferred, onsite 3 days per week with remote flexibility and travel to site as needed.
Office hours 8am-5pm Pacific Time.
Responsibilities
Provide Quality Engineering leadership for software and hardware product development teams.
Lead design control risk management and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross‑functional product development team members.
Lead the development and maintenance of the Risk Management File (RMF), including risk management plans, hazard analysis, dFMEAs, pFMEAs and the risk management report.
Provide Quality Engineering input for review and approval of the Design History File (DHF) and associated documentation; oversee quality oversight and approval of product development plans, design inputs/outputs, verification and validation, and review of test plans, protocols and reports.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the subject matter expert for software quality; collaborate with teams on code reviews, software security analysis, and the software BOM lead implementation of best practices for software quality processes.
Participate in design reviews to ensure effective development, transfer and maintenance of the product hardware and software throughout the product lifecycle.
Support the successful transfer and hyper‑care phase of design and design modifications into production/field deployment.
Provide Quality Engineering support for anomalies (software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects; guide triage and remediation efforts.
Secondary / Backup Responsibilities
Lead changes to the Quality System based on new regulations, guidance documents, industry standards and observations.
Own the resolution and timely closure of CAPAs as they relate to the design control process.
Provide Quality Engineering support for released products interfacing with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management.
Qualifications
8 years of progressive Quality Engineering experience in the medical device industry with hands‑on support for hardware and software development.
Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304 and IEC 62366.
Experience in the design, development, verification, validation and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non‑embedded software.
Experience in the deployment of quality engineering tools for design and process improvement and extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with the ability to manage multiple projects independently while prioritizing work and advocating for quality and regulatory compliance.
Comfortable working in a high‑growth company with rapidly evolving needs, responsibilities and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis software (e.g., Minitab) and other business software.
Additional Qualifications
Certified ASQ CQE and/or Six Sigma Black Belt/Green Belt preferred.
Experience with artificial intelligence working within an AAMI TIR45 framework and SaMD is preferred.
Experience supporting development of classic and artificial intelligence AI software algorithms and deep understanding of cloud infrastructure is preferred.
Education and Experience
B.S./M.S. in a relevant engineering field (e.g., biomedical software, electrical engineering, etc.) or equivalent scientific degree.
Physical Demands and Work Environment
Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
Experience Level Intermediate Level
Pay and Benefits
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan (Pre‑tax and Roth post‑tax contributions available)
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Application Deadline This position is anticipated to close on Oct 28, 2025.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, please email actalentaccommodation@actalentservices.com for additional accommodation options.
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